Washington, D.C. – U.S. Sen. Mike Enzi, R-Wyo., applauded President Bush's initiative designed to improve access to generic drugs.

The Federal Drug Administration (FDA) released draft regulations this week that would enhance access to safe and effective, yet inexpensive, generic alternatives to brand-name drugs. The new rule is designed to help consumers gain access to generic drugs. The new rule would curb the practice of repeated court battles over patent infringements and clarify the patent process.

"The administration's response is a much more reasonable approach than the Senate bill (S.812) passed earlier this year," said Enzi who fought to improve the bill, but ultimately could not support the legislation. "The new rule improves current law without enacting major detrimental changes to the Hatch-Waxman provisions."

The President expects the proposed rule to save America's prescription drug consumers over $3 billion per year with this proposal.

Since the 1984 passage of the landmark Hatch-Waxman law, which governs how generic drugs can compete with brand-name drugs, the sale of generic drugs in the U.S. has more than doubled. But, Enzi said, increasing healthcare costs-specifically the cost for pharmaceuticals-are making health care unaffordable for too many Americans.

Drug-makers have used certain provisions in the Hatch-Waxman Act that have countered the benefits of the law by delaying the availability of generic drugs to America's consumers. The new rule would restrict drug-makers to one 30-month "automatic stay" in court. Under FDA's past interpretations of the Hatch-Waxman law, drug manufacturers have been able to file additional patents on packaging, ingredient combinations, and other minor matters to obtain repeated "automatic stays" in court that delayed access to generic drugs.

Enzi is a member of the Senate Health, Education, Labor and Pensions (HELP) committee. He has been recognized for his work on the Patients' Bill of Rights Act and other healthcare initiatives.